The USPTO has devised a plan to address the IDS PTA deduction error that incorrectly charges a Patent Term Adjustment (PTA) deduction for Information Disclosure Statements (IDSs) filed with a “safe harbor” statement. Although the USPTO won’t be able to correct the underlying problem until it rolls out its “next generation” information technology systems, it has devised a plan to make it easier for applicants to flag safe harbor IDSs, and easier–and cheaper–to request recalculation of a PTA award when this is the only error.

The IDS PTA Deduction Error

I first wrote about the IDS PTA deduction error in this article. There I explained that the USPTO treats an IDS filed after a response or Request for Continued Examination (RCE) as a “supplemental reply or other paper” that can trigger a PTA deduction for “Applicant Delay.” However, the USPTO rules provide that no PTA deduction will be taken if the IDS is filed to submit items cited by the USPTO or a foreign patent office within 30 days of the submission and is accompanied by a statement under 37 CFR § 1.704(d)–a “safe harbor” statement. Unfortunately, the USPTO charges a PTA deduction anyway, because the computer program it uses to calculate PTA “cannot determine whether a compliant safe harbor statement” was made.

Although applicants can request reconsideration of PTA awards that erroneously include this deduction, until now doing so required a $200 fee–not to mention time to identify the error, prepare and file the petition, and ensure a Certificate of Correction is granted.

Interim Procedure for Requesting Recalculation of PTA Based On Safe Harbor IDS Error

As announced in the November 2, 2018 Federal Register Notice and effective immediately, there is a new way applicants can request recalculation of PTA where the onlyerror “is the USPTO’s failure to recognize a timely filed safe harbor statement” filed with an IDS that triggered an erroneous deduction. Under this interim procedure, the fee for requesting reconsideration of PTA is waived. According to the Notice, this “interim” procedure “will remain in effect until the USPTO can update the patent term adjustment computer program.”

If an applicant seeks correction of any other PTA errors, a request for reconsideration should be filed under 37 CFR 1.705(b) with the requisite fee.

Please see the full Federal Register Notice for more details on how to submit a request for recalculation and how the request will be processed.

New Form For Safe Harbor Statements

The USPTO also has created a new form for safe harbor statements. Applicants are notrequiredto use the form for a Patent Term Adjustment Statement under 37 CFR 1.704(d), but doing so will help the USPTO avoid making the IDS PTA deduction error in the future. In particular, according to the Notice, the USPTO’s updated PTA computer program will “recognize when form PTO/SB/133 has been filed” and will “tak[e] into account that applicant filed a compliant safe harbor statement under 37 CFR 1.704(d) when it performs the patent term adjustment calculation.”

That is, as emphasized in the Notice:

As a result of using the form, the USPTO’s computer program, once updated, will take the safe harbor statement into account when patent term adjustment is calculated, thereby eliminating the need to file a request for reconsideration of patent term adjustment under 37 CFR 1.705(b) for this matter.

Easing The Burden On Applicants

While it’s frustrating that the USPTO hasn’t yet been able to correct the underlying problem, it’s encouraging that the USPTO has implemented these procedures to ease the burden on applicants–and waive the $200 fee heretofore required to get the USPTO to correct its systemic error.

]]>https://www.pharmapatentsblog.com/2018/11/06/uspto-addresses-ids-pta-deduction-error/feed/0When Does An RCE Stop The PTA Clock?https://www.pharmapatentsblog.com/2018/02/13/when-does-an-rce-stop-the-pta-clock/
https://www.pharmapatentsblog.com/2018/02/13/when-does-an-rce-stop-the-pta-clock/#respondTue, 13 Feb 2018 06:00:58 +0000https://www.pharmapatentsblog.com/?p=7373
In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must award Patent Term Adjustment (PTA) for “B” delay. Under the USPTO’s rules, filing a Request for Continued Examination...… Continue reading this entry]]>

In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must award Patent Term Adjustment (PTA) for “B” delay. Under the USPTO’s rules, filing a Request for Continued Examination (RCE) stops that PTA clock, but in Ariad Pharmaceuticals, Inc. v. Matal, the U.S. District Court for the Eastern District of Virginia found that the clock should keep running when the USPTO mishandles an RCE. So, exactly when does an RCE stop the PTA clock?

The PTA Statute At Issue

The PTA statute at issue in this case is 35 USC § 154(b)(1)(B)(i), which provides:

(B) GUARANTEE OF NO MORE THAN 3-YEAR APPLICATION PENDENCY.- Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application in the United States, not including–(i) any time consumed by continued examination of the application requested by the applicant under section 132(b) ….

The USPTO’s interpretation of this provision is set forth in 37 CFR § 1.703(b)(1):

(b) The period of adjustment under § 1.702(b) is the number of days, if any, in the period beginning on the day after the date that is three years after the date on which the application was filed under 35 USC 111(a) or the national stage commenced under 35 USC 371(b) or (f) in an international application and ending on the date a patent was issued, but not including the sum of the following periods:(1) The number of days, if any, in the period beginning on the date on which a request for continued examination of the application under 35 USC 132(b) was and ending on the date of mailing of the notice of allowance under 35 USC 151 ….

Thus, under the USPTO’s rule, once an RCE is filed, the patent no longer accrues “B” delay, although it might still accrue “A” delay and/or “C” delay. (Please see this article for a more detailed discussion of this issue and the PTA framework.)

The Ariad Patent Prosecution History

The Ariad patent at issue is U.S. Patent No. 8, 114,874. During prosecution, Ariad filed an RCE, but the USPTO mishandled it and issued a Notice of Abandonment that took four months rescind:

(Excerpt from the PAIR Transaction History record for U.S. Patent No. 8, 114,874)

When the USPTO calculated PTA for the patent, it applied Rule 703(b)(i) and excluded the entire time from the mishandled RCE to the subsequent Notice of Allowance from its “B” delay calculation.

The PTA Issue On Appeal

Ariad appealed the USPTO’s PTA award to the U.S. District Court for the Eastern District of Virginia. The court summarized the issues presented as follows:

The PTO contends that “time consumed by continued examination” includes any time after the filing of an RCE, which occurred in February 2010, and as such, the time from February to June was properly excluded. ARIAD counters by arguing that time during which the PTO erroneously considered the application abandoned and therefore did not conduct continued examination should not be excluded and that this time should be credited to ARIAD as “B Delay.”

The district court (Judge Ellis, III) found that the plain language of the statute and the purpose of the statute supported Ariad’s position:

To begin with, it is important to note that Congress did not use the phrase—“time after the applicant filed a request for continued examination” … in the statutory text. Instead, Congress chose to draft the provision as “any time consumed by continued examination of the application requested by the applicant.”

Time cannot possibly be used in the course of continued examination where, as here, the PTO erroneously determines the application is abandoned and does not believe it has even received an RCE.

The court continued:

ARIAD’s interpretation of the statute also comports with the purpose of this statutory provision. The legislative history of the AIPA suggests that Congress intended the “B Delay” exclusions to include delay attributable to the applicant, and not to the PTO.

The delay here was indisputably attributable to the PTO; the delay was not the result of the applicant’s request for continued examination but rather the delay in question was the result of the PTO’s erroneous notice of abandonment.

The USPTO argued that under Ariad’s interpretation it would be too burdensome to identify and account for days of actual continued examination (e.g., days the examiner actually examined the application at issue), but the court did not require such a granular application of the statute:

If, as the statute suggests, “time consumed by continued examination” begins when the RCE is forwarded to the patent examiner, the PTO would not need to determine which days the patent examiner actually engaged in continued examination because the clock would begin to run as soon as the request was forwarded.

The court refused to give deference to the USPTO’s construction, either as being “contrary to the plain language of an unambiguous statute” or as a procedural rule not entitled to Chevron deference.

Thus, the court granted summary judgment in favor of Ariad.

When Does an RCE Stop the PTA Clock?

The district court’s decision seems fair on the facts presented. Why should Ariad be denied PTA for examination delays due to the USPTO’s errors? A question remains, however, as to whether the court’s decision invalidates Rule 703(b)(i) in all cases, or only “as applied to these facts.” Does the USPTO need to rewrite the rule to start the excluded time period on the date on which an application is forwarded to the examiner after an RCE has been filed? Or does it only need to account for a lack of post-RCE examination diligence when it mishandles an RCE?

Anecdotally, it appears that it typically may take a few days after an RCE is filed for an application to be forwarded to the examiner, at least according to Transaction History records on PAIR.

]]>https://www.pharmapatentsblog.com/2018/02/13/when-does-an-rce-stop-the-pta-clock/feed/0USPTO Patent Term Adjustment Error Costs Patent Owners Time And Moneyhttps://www.pharmapatentsblog.com/2017/05/16/patent-term-adjustment-error/
https://www.pharmapatentsblog.com/2017/05/16/patent-term-adjustment-error/#commentsTue, 16 May 2017 05:00:23 +0000https://www.pharmapatentsblog.com/?p=7142
The USPTO appears to have dropped its plans to overhaul the Information Disclosure Statement (IDS) process, but that’s no excuse for its failure to process IDSs in accordance with its current rules. Most egregiously, the USPTO erroneously charges a Patent Term Adjustment (PTA) deduction for IDSs filed with a Rule 704(d) statement because its PTA...… Continue reading this entry]]>

The USPTO appears to have dropped its plans to overhaul the Information Disclosure Statement (IDS) process, but that’s no excuse for its failure to process IDSs in accordance with its current rules. Most egregiously, the USPTO erroneously charges a Patent Term Adjustment (PTA) deduction for IDSs filed with a Rule 704(d) statement because its PTA calculation process fails to determine whether such a statement was included. While patent owners can file an application to be awarded that PTA, such an application requires a $200 fee–not to mention time to identify the error, prepare and file the petition, and ensure a Certificate of Correction is granted.

The IDS Patent Term Adjustment Penalty

The USPTO treats an IDS filed after a response or Request for Continued Examination (RCE) as a “supplemental reply or other paper” that can trigger a PTA deduction for “Applicant Delay.” The USPTO cites 37 CFR § 1.704(c)(8) as providing for such a deduction even if the IDS is timely under the IDS rules.

The USPTO rules promise that no PTA deduction will be taken if the IDS is filed to submit items cited by the USPTO or a foreign patent office within 30 days of the submission. In particular, 37 CFR § 1.704(d) provides:

A paper containing only an information disclosure statement … will not be considered a failure to engage in reasonable efforts to conclude prosecution … under paragraphs (c)(6), (c)(8), (c)(9), or (c)(10) of this section, … if the paper … is accompanied by a statement that each item of information contained in the information disclosure statement:
(i) Was first cited in any communication from a patent office in a counterpart foreign or international application or from the Office, and this communication was not received by any individual designated in § 1.56(c) more than thirty days prior to the filing of the information disclosure statement; or
(ii) Is a communication that was issued by a patent office in a counterpart foreign or international application or by the Office, and this communication was not received by any individual designated in § 1.56(c) more than thirty days prior to the filing of the information disclosure statement.

Thus, if the applicant is able to act quickly, the IDS PTA penalty can be avoided if the items to be submitted were cited in a counterpart foreign or international application or by the USPTO, and if the applicant includes a Rule 704(d) statement in the submission.

The IDS Patent Term Adjustment Error

Unfortunately for applicants, the USPTO PTA calculation process does not always involve determining whether an IDS filed after a response or RCE included a Rule 704(d) statement. Thus, the USPTO often charges a PTA deduction under 37 CFR § 1.704(c)(8) even though such a deduction is improper under 37 CFR § 1.704(d).

The PTA Correction Process

When the USPTO makes an error in its PTA calculation, a patent owner can seek correction by filing an “application for patent term adjustment” under 37 CFR § 1.705(b). Such an application requires “[a] statement of the facts involved” and “[t]he fee set forth in § 1.18(e),” which currently is $200.

While applications to correct this Rule 704(d) error are routinely granted, another glitch in the PTA process imposes additional burdens on patent owners to ensure that the USPTO follows through with the correction. Although the USPTO should automatically issue a Certificate of Correction when its PTA redetermination results in a different PTA award (see MPEP § 2754), the USPTO sometimes fails to take that last, important step. This may be because there is no automatic mechanism that sends a patent to the Certificates of Correction branch once a PTA redetermination has been made. Thus, once their PTA applications have been granted, patent owners may need to contact someone in the Certificates of Correction branch themselves to advise them of the need for a Certification of Correction to complete the PTA correction process.

Undue Burdens On Patent Owners

The USPTO’s failure to confirm that an IDS filed after a response or RCE did not include a Rule 704(d) statement before charging a PTA deduction forces patent owners to bear the costs of this error. Patent owners need to have their own mechanisms in place to identify this PTA error, prepare and file an application for corrected PTA with a $200 fee, and follow up with the USPTO to ensure a Certificate of Correction is granted. This is an undue and unacceptable burden when systemic shortcomings in the USPTO’s own processes are at the root of PTA errors that impact numerous patent owners.

]]>https://www.pharmapatentsblog.com/2017/05/16/patent-term-adjustment-error/feed/3District Court Denies Extra Patent Term Adjustment When National Stage Entry Date Falls On A Holidayhttps://www.pharmapatentsblog.com/2016/10/27/district-court-denies-extra-patent-term-adjustment-when-national-stage-entry-date-falls-on-a-holiday/
https://www.pharmapatentsblog.com/2016/10/27/district-court-denies-extra-patent-term-adjustment-when-national-stage-entry-date-falls-on-a-holiday/#respondThu, 27 Oct 2016 05:00:46 +0000https://www.pharmapatentsblog.com/?p=6932
Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a U.S. national stage application when the 30-month national stage entry days falls on a Federal holiday? Judge O’Grady of the...… Continue reading this entry]]>

Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a U.S. national stage application when the 30-month national stage entry days falls on a Federal holiday? Judge O’Grady of the U.S. District Court for the Eastern District of Virginia agreed with the USPTO that the clock does not start to run until the next business day.

Type “A” Delay Under The PTA Statute

The PTA statute (35 USC § 154(b)) was created to compensate for delays in the patent examination process that can erode the effective term of a patent, which is measured from the patent’s earliest non-provisional U.S. priority date. The statute provides “guarantees” against different types of USPTO delays, and requires a day-for-day deduction of Applicant delays against USPTO delays.

The issue in Acetelion relates to “A” delay, which accrues when the USPTO fails to act in accordance with set time frames including failing to issue a “notification under section 132” (e.g., a Restriction Requirement or Office Action) within 14 months of “(I) the date on which an application was filed under section 111(a); or (II) the date of commencement of the national stage under section 371 in an international application.”

Starting The 14-Month Clock In U.S. National Stage Applications

Under the America Invents Act Technical Corrections Act (AIA TCA) (effective Jan. 14, 2013), the 14-month clock begins to run in a U.S. national stage application on “the date of commencement of the national stage.” Under the PCT, the national stage of examination will not commence until “expiration of 30 months from the priority date,” unless an applicant makes an “express request” for early examination. See PCT Article 23. In accordance with PCT rules, if “the expiration of any period” falls on an official holiday for the patent office at issue, then “the period shall expire on the next subsequent [business] day.” See PCT Rule 80.5.

The Acetelion National Stage Timeline

The patent at issue in Acetelion was granted from a U.S. national stage application filed January 12, 2012. According to the district court decision, the application was filed with “a Form PT0-1390 Transmittal Letter,” on which the applicant did notcheck the box indicating that the application was “an express request to begin national examination procedures.” However, the application also was filed with a Preliminary Amendment which included a statement that “Applicant earnestly solicits early examination and allowance of these claims. ….”

On January 26, 2012, the USPTO issued a Filing Receipt indicating receipt of the “35 U.S.C. §§ 375 (c)(l), (c)(2), and (c)(4) REQUIREMENTS” on January 12, 2012 and designating January 16, 2012 as the “DATE OF COMPLETION OF ALL 35 U.S.C. § 371 REQUIREMENTS[.]” However, January 16, 2012, was Martin Luther King, Jr. Day.Thus, when the USPTO calculated A delay for the patent, it started the 14-month clock on January 17, 2012.

Does The PCT Holiday Rule Impact PTA?

One of Acetelion’s arguments was that the USPTO abused its discretion when it started the the 14-month clock on January 17, 2012, instead of January 16, 2012. The USPTO justified this calculation based on PCT Rule 80.5, but Acetelion argued that the rule only should be invoked to help, not hurt, applicants:

[T]he weekend/holiday extension should only apply where a filer’s right would be protected by extending the deadline to the next business day whereas here, the length of Plaintiffs PTA and the rights associated with the increased patent term duration are constrained by the extension.

Acetelion also noted that the USPTO did not have to take any action in order for the 30 month period to expire, such that the timing of the holiday was irrelevant. The court rejected these arguments:

Because a filer can take actions on the expiration date, the PTO must be available to receive and take action on such filings–which is not possible on a weekend or federal holiday… Accordingly, [the USPTO’s] decision to apply the weekend/holiday exception is consistent with the interpretation of similar statutory provisions and is not a clear error of judgment.

The court therefore granted summary judgment in favor of the USPTO.

What About The Filing Receipt?

One dissatisfying aspect of this decision is the court’s failure to address the January 16, 2012 date listed on the Filing Receipt. Another dissatisfying aspect of this decision is the presumption that the USPTO must be able to “receive and take action” on the date submissions are made. Does the court think USPTO personnel review every document on the day it’s filed?

]]>https://www.pharmapatentsblog.com/2016/10/27/district-court-denies-extra-patent-term-adjustment-when-national-stage-entry-date-falls-on-a-holiday/feed/0Court Can't Review Policy Behind Patent Term Adjustment Statutehttps://www.pharmapatentsblog.com/2016/04/14/court-cant-review-policy-behind-patent-term-adjustment-statute/
https://www.pharmapatentsblog.com/2016/04/14/court-cant-review-policy-behind-patent-term-adjustment-statute/#respondThu, 14 Apr 2016 05:00:44 +0000https://www.pharmapatentsblog.com/?p=6567
In Singhal v. Lee, the U.S. District Court for the Eastern District of Virginia dismissed a complaint that challenged the Patent Term Adjustment (PTA) awarded to two patents, because the complaint failed to state a claim upon which relief could be granted. Ms. Singhal challenged the “RCE carve-out” on policy grounds, but federal courts lack authority to...… Continue reading this entry]]>

In Singhal v. Lee, the U.S. District Court for the Eastern District of Virginia dismissed a complaint that challenged the Patent Term Adjustment (PTA) awarded to two patents, because the complaint failed to state a claim upon which relief could be granted. Ms. Singhal challenged the “RCE carve-out” on policy grounds, but federal courts lack authority to re-write statutes on that basis.

The Patent Term Adjustment At Issue

The patents at issue were U.S. 8,090,945 and U.S. 8,103,246, which Ms. Singhal appears to have filed and prosecuted per se. The prosecution of both patents included the filing of one or more Requests for Continued Examination (RCEs). When calculating PTA, the USPTO applied 35 USC 154(b)(2)(B) and did not award any PTA for B-delay that occurred after the RCEs were filed.

You can read more about the RCE carve-out here. Ms. Singhal’s complaint was filed before the Federal Circuit rejected part of the USPTO’s carve-out rule in Novartis v. Lee, which you can read about here.

One of Ms. Singhal’s arguments was that the RCE carve-out unjustly penalized applicants who “often have good reason to request continued examination of an application.” For example, Ms. Singhal faced several “final” Office Actions that made new prior art rejections, requiring her to file an RCE in order to amend the claims to overcome the new rejections. Without addressing that position on the merits, the court noted that it lacks authority to re-write the statute:

Courts including the Federal Circuit in interpreting § 154 itself – have repeatedly held that they lack authority to re-write a statute simply because a Plaintiff “believes that the delicate balance that Congress struck was erroneous, unwise, or somehow inequitable.”

Additional PTA Under Novartis

Even is Ms. Singhal is not entitled to the additional PTA she sought, she might be able to obtain additional PTA under Novartis. That could amount to about three additional months of PTA for the ‘845 patent and four additional months of PTA for the ‘246 patent. According to one of the papers filed by the USPTO in this case, the USPTO may recalculate the PTA for both patents consistent with Novartis once this district court proceeding is terminated.

]]>https://www.pharmapatentsblog.com/2016/04/14/court-cant-review-policy-behind-patent-term-adjustment-statute/feed/0Patent Term Adjustment In South Koreahttps://www.pharmapatentsblog.com/2016/03/17/patent-term-adjustment-in-south-korea/
https://www.pharmapatentsblog.com/2016/03/17/patent-term-adjustment-in-south-korea/#respondThu, 17 Mar 2016 05:00:49 +0000https://www.pharmapatentsblog.com/?p=6532
According to this bulletin from Lee International IP & Law Group in South Korea, Korean patents filed on or after March 2012 may be entitled to Patent Term Adjustment if they issued more than 4 years after the filing date and more than three years after a request for examination was filed. Patent Term Adjustment...… Continue reading this entry]]>

According to this bulletin from Lee International IP & Law Group in South Korea, Korean patents filed on or after March 2012 may be entitled to Patent Term Adjustment if they issued more than 4 years after the filing date and more than three years after a request for examination was filed.

Patent Term Adjustment Under Article 92(2) of the Korean Patent Act

Like the U.S. Patent Term Adjustment statute, Article 92(2) of the Korean Patent Act calls for deductions from a PTA award for applicant delay, but it appears that KIPO even will count the time between an Office Action and a timelyfiled response as “delay” if the response included any claim amendments, and also will count as delay every day between the date a Notice of Allowance is mailed and the date the issue fee is paid. The PTA available under this statute is similar to an award of PTA for “B” type delay in the U.S., since every day after the four/three year period counts as KIPO delay.

Unlike PTA for U.S. patents, patent owners must request a determination of PTA, and must do so within three months of when the issue fee is paid.

]]>https://www.pharmapatentsblog.com/2016/03/17/patent-term-adjustment-in-south-korea/feed/0Patent Term Adjustment Versus Double Patentinghttps://www.pharmapatentsblog.com/2016/02/25/patent-term-adjustment-versus-double-patenting/
https://www.pharmapatentsblog.com/2016/02/25/patent-term-adjustment-versus-double-patenting/#respondThu, 25 Feb 2016 06:00:25 +0000https://www.pharmapatentsblog.com/?p=6491
In Magna Electronics, Inc. v. TRW Automotive Holdings Corp., No. 1:12-cv-654; 1:13-cv-324 (Dec. 10, 2015), Judge Maloney of the U.S. District Court for the Western District of Michigan granted TRW’s motion for partial summary judgement of invalidity based on obviousness-type double patenting over a later-granted child patent. While it was only a matter of time before...… Continue reading this entry]]>

In Magna Electronics, Inc. v. TRW Automotive Holdings Corp., No. 1:12-cv-654; 1:13-cv-324 (Dec. 10, 2015), Judge Maloney of the U.S. District Court for the Western District of Michigan granted TRW’s motion for partial summary judgement of invalidity based on obviousness-type double patenting over a later-granted child patent. While it was only a matter of time before the Federal Circuit decision in Gilead was applied in this manner, these circumstances raise important issues that should be given separate consideration. Since Magana and TRW have settled this litigation, we will have to wait for another case to determine whether parent-child obviousness-type double patenting can obliterate Patent Term Adjustment.

The Patent At Issue

The patent at issue was Magna’s U.S. Patent 7,339,149 which was filed November 16, 1999 with a priority claim to February 26, 1993, and issued March 4, 2008, after an interference proceeding. The patent was awarded 498 days of Patent Term Adjustment based on the interference.

The cited patent was U.S. Patent 7,402,786, filed October 6, 2006 as a continuation of the ‘149 patent. The ‘786 patent issued July 22, 2008 with 63 days of Patent Term Adjustment, but expired February 26, 2013 (twenty years from the priority date of the ‘149 patent) because of a Terminal Disclaimer over U.S. Patent 7,388,182, which was a grandchild of the ‘149 patent that did not earn any Patent Term Adjustment.

Thus, the challenged patent was a parent patent that had earned Patent Term Adjustment, while the cited patent was its later-granted child patent with a twenty-year term.

The Gilead Decision

The district court cited the Federal Circuit decision in Gilead Sciences, Inc. v. Natco Pharma Limited, for the principle that the later-granted ‘182 patent could be cited as an obviousness-type double patenting reference against the ‘149 patent. As explained in this article, in Gilead the Federal Circuit determined that “a patent that issues after but expires before another patent can qualify as a double patenting reference for that other patent.” Although the Federal Circuit qualified its holding as applying “under the circumstances of this case,” the district court did not address the possibility that a parent-child scenario amounted to different circumstances.

The End Of Patent Term Adjustment?

Parent patents often experience a longer examination process, and may earn considerable Patent Term Adjustment if they are granted after a successful appeal of an examiner’s rejection to the Patent Trial and Appeal Board. On the other hand, a parent patent may have narrower claims than a subsequently granted child patent, and may recite a species (e.g., lead compound, approved product, or commercial embodiment) that is anticipated by a genus claimed in the child patent. Thus, if a child patent can be cited against its parent, it often may be difficult to distinguish the claims on the merits.

But the patents at issue in Gilead were not parent-child patents. Thus, a parent-child scenario may not be “under the circumstances” presented in Gilead. One important issue that was not addressed in Gilead is whether the judicially-created doctrine of obviousness-type double patenting can (or should) take precedence over the statutory grant of Patent Term Adjustment.

]]>https://www.pharmapatentsblog.com/2016/02/25/patent-term-adjustment-versus-double-patenting/feed/0Incomplete Restriction Requirement Stops Clock For Patent Term Adjustmenthttps://www.pharmapatentsblog.com/2016/01/26/no-patent-term-adjustment-for-incomplete-action/
https://www.pharmapatentsblog.com/2016/01/26/no-patent-term-adjustment-for-incomplete-action/#respondTue, 26 Jan 2016 06:00:18 +0000https://www.pharmapatentsblog.com/?p=6457
In Pfizer v. Lee, the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Virginia that upheld the USPTO’s Patent Term Adjustment (PTA) calculation that stopped the clock running against the USPTO when the examiner issued an incomplete Restriction Requirement. This decision is not surprising, but Applicants should remember that...… Continue reading this entry]]>

In Pfizer v. Lee, the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Virginia that upheld the USPTO’s Patent Term Adjustment (PTA) calculation that stopped the clock running against the USPTO when the examiner issued an incomplete Restriction Requirement. This decision is not surprising, but Applicants should remember that they are held to a different standard under the PTA rules.

Patent Term Adjustment

It’s been a while since I’ve written about Patent Term Adjustment, so here’s a refresher on the basics:

The PTA statute (35 USC § 154(b)) was created to compensate for delays in the patent examination process that can erode the effective term of a patent, which is measured from the patent’s earliest non-provisional U.S. priority date. The statute provides “guarantees” against different types of USPTO delays, and requires a day-for-day deduction of Applicant delays against USPTO delays.

“A” delay accrues when the PTO fails to act in accordance with set time frames (such as issuing a first Office Action within 14 months, issuing a second action or allowance within 4 months of a response, and issuing a patent within 4 months of the Issue Fee payment).

“B” delay accrues when the PTO fails to issue a patent within three years of the actual filing date of the patent application.

“C” delay accrues when the application is involved in an interference or appeal, or is subject to a secrecy order.

The issue in this case relates to the amount of A delay the patent should have been awarded for the USPTO’s failure to meet the time frames set forth in 35 USC §154(b)(1)(A).

The USPTO Delay At Issue

The patent at issue was Pfizer’s U.S. Patent No. 8,153,768, directed to certain chemotherapeutic agents. The relevant events for the PTA dispute are outlined below:

*The first Restriction Requirement was incomplete in that it did not address all of the dependent claims.

The USPTO awarded 404 days of PTA for the delay running from June 2, 2004, to August 10, 2005. Pfizer challenged that award, seeking an additional 197 days of PTA based on the date of the second Restriction Requirement.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge O’Malley and joined by Judge Dyk. Judge Newman dissented.

Under the PTA statute, the USPTO has fourteen months from an application’s filing date to issue “at least one of the notifications under section 132 or a notice of allowance under section 151.” At issue was whether the incomplete Restriction Requirement qualified as “notification[] under section 132.”

35 USC § 132 states in relevant part:

(a) Whenever, on examination, any claim for a patent is rejected, or any objection or requirement made, the Director shall notify the applicant thereof, stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application; and if after receiving such notice, the applicant persists in his claim for a patent, with or without amendment, the application shall be reexamined. ….

Pfizer argued that the incomplete Restriction Requirement “failed to satisfy the notice requirement of Section 132 because it failed to classify six dependent claims … and thus failed to place the applicants on notice of the restriction requirement as to those dependent claims.” The Federal Circuit rejected that argument:

The examiner’s initial requirement satisfied the statutory notice requirement because it informed the applicant of “the broad statutory basis for [the rejection of] his claims.” Chester [v. Miller], 906 F.2d [1574,] at 1578 [(Fed. Cir. 1990)]. Here, the examiner’s detailed descriptions of the 21 distinct invention groups outlined in the examiner’s initial restriction requirement were clear, providing sufficient information to which the applicants could have responded. …. And, significantly, the examiner’s defined invention groups remained identical between the two restriction
requirements. ….

As for the six claims whose classifications were omitted from the initial restriction requirement, …. the dependent claims would naturally have been classified in a subset of the invention groups to which the claims they depend from belong.

The court also noted that the “Summary” of the Restriction Requirement noted that all claims were subject to restriction, and that MPEP § 814 “supports the PTO’s position that the original restriction requirement satisfied the notice requirements of Section 132,” where it provides:

While every claim should be accounted for, the omission to group a claim, or placing a claim in the wrong group will not affect the propriety of a final requirement where the requirement is otherwise proper and the correct disposition of the omitted or erroneously grouped claim is clear.

Thus, the court upheld the USPTO’s determination that the incomplete Restriction Requirement stopped the fourteen-month clock from running, e.g., stopped further accrual of “A” Delay.

Judge Newman’s Dissent

In her dissent, Judge Newman emphasized that it was undisputed that the incomplete Restriction Requirement delayed prosecution, and criticizes the majority for inexplicably shifting the blame for that error to the Applicant.

The panel majority holds that this period of delay should be attributed to the applicant, not the PTO. This is indeed curious, for the applicant made no error. The panel majority holds that PTO error does not count if the applicant could have figured out what the examiner might have done if he had not erred. The panel majority appears to believe that this would have eliminated the delay consumed by the correction of the error. However, the prosecution was delayed by the PTO’s error.

*****

The statutory purpose is clear: when patent issuance is delayed because of proceedings that are not the fault of the applicant, the patent term is extended to compensate for the delay. H.R. Rep No. 106-287, at 49 (1999) (“Title III amends the provisions in the Patent Act that compensate patent applicants for certain reductions in patent term that are not the fault of the applicant.”). My colleagues’ statutory interpretation and application are contrary to the letter and purpose of the law. I respectfully dissent.

Applicants Are Held To A Different Standard

Although the court here seems to hold that a substantially complete Office Action can stop the PTA delay clock that runs against the USPTO, Applicants are held to a different standard under 37CFR 1.704(c)(7) and (8). Those rules call for PTA deductions when an Applicant submits an incomplete reply or a supplemental response. In both cases, the deduction runs from the day after the initial reply was filed until the day the second reply was filed.

Did the Federal Circuit realize that USPTO PTA rules hold Applicants to a different standard?

]]>https://www.pharmapatentsblog.com/2016/01/26/no-patent-term-adjustment-for-incomplete-action/feed/0Federal Circuit Upholds USPTO Post-Wyeth Patent Term Adjustment Procedureshttps://www.pharmapatentsblog.com/2015/07/07/post-wyeth-patent-term-adjustment-procedures/
https://www.pharmapatentsblog.com/2015/07/07/post-wyeth-patent-term-adjustment-procedures/#respondTue, 07 Jul 2015 05:00:11 +0000http://www.pharmapatentsblog.com/?p=6155
In Daiichi Sankyo Co. v. Lee, the Federal Circuit upheld the USPTO’s post-Wyeth Patent Term Adjustment (PTA) procedures, and found that the USPTO did not abuse its discretion when it limited the Interim Procedures to petitions filed within 180 days of the patent’s grant date. This decision highlights the deferential standard of review applied to USPTO...… Continue reading this entry]]>

In Daiichi Sankyo Co. v. Lee, the Federal Circuit upheld the USPTO’s post-Wyeth Patent Term Adjustment (PTA) procedures, and found that the USPTO did not abuse its discretion when it limited the Interim Procedures to petitions filed within 180 days of the patent’s grant date. This decision highlights the deferential standard of review applied to USPTO procedures implemented under its rule-making authority.

The Patents At Issue

The patents at issue were U.S. Patent 7,342,014 (granted March 11, 2008) and U.S. Patent 7,365,205 (granted April 29, 2008). Also relevant to the underlying facts was U.S. Patent 7,576,135 (granted August 18, 2009).

The ‘135 patent was terminally disclaimed over the ‘014 and ‘205 patents, which were terminally disclaimed over each other. Thus, by operation of the terminal disclaimers filed in each of the underlying applications, all three patents would expire on the earliest expiration date of any of the three patents.

The Patent Term Adjustment Problem

I first wrote about this case here, after the district court rendered its decision in 2013. As explained in that article, Daiichi Sankyo filed suit against the USPTO in February of 2010 to obtain additional PTA for the ‘135 patent under the Federal Circuit’s Wyeth decision, which was issued in early 2010. Daiichi Sankyo prevailed in that case, but could not benefit from the additional PTA because of the terminal disclaimers filed against the ‘014 and ‘205 patents. Thus, in November of 2010, Daiichi Sankyo filed an amended complaint seeking addition PTA for the ‘014 and ‘205 patents, also under Wyeth.

The district court granted summary judgment in favor of the USPTO, upholding the USPTO’s determinations that Daiichi Sankyo’s attempts to obtain additional PTA for the ‘014 and ‘205 patents were untimely.

The USPTO’s Post-Wyeth Procedures

After Wyeth, the USPTO implemented “Interim Procedures” for requesting reconsideration of PTA awards under Wyeth, and made those procedures available to any patent issued within 180 days of the request. In effect, the Interim Procedures extended the normal 2 month post-grant time period for requesting reconsideration to 180 days for Wyeth issues. The USPTO had justified this 180 day time period as corresponding to the statutory time period for bringing a civil action to challenge PTA. In particular, the PTA statute in effect at the time required a patentee “dissatisfied with a [PTA] determination made by the Director [of the USPTO]” to bring a civil action “within 180 days after the grant of the patent.”

The Federal Circuit Decision

The Federal Circuit Decision was authored by Judge Reyna and joined by Judges Moore and Taranto.

The Federal Circuit focused on the propriety of the USPTO’s post-Wyeth procedures. Daiichi Sankyo argued that the time period for judicial review should not be read as limiting the time period for administrative review, and that the statute governing certificates of correction (35 USC § 254) reflected Congressional intent to permit the USPTO to correct its own mistakes at any time.

The Federal Circuit noted that the Administrative Procedure Act calls for a deferential review of an agency decision like the one at issue, and found that the USPTO had “acted within its discretion under the statute to ‘prescribe regulations establishing procedures for the . . . determination of patent term adjustments,'” as set forth in 35 USC § 154(b)(3). The court found no abuse of discretion in the USPTO’s handling of the patents at issue, finding that “[t]he PTO’s conclusion that its authority to conduct administrative reviews extends no further than the period for judicial review is … consistent with the statute, which expressly authorizes the PTO to make regulations governing the procedures of patent term adjustment reconsiderations.”

The Federal Circuit also rejected the argument that the Interim Procedures resulted in disparate treatment of Daiichi Sankyo’s patents that could not benefit from them, because “[a]ll other similar requests were denied by the agency, showing that the PTO acted consistently with respect to similarly situated patentees.”

[T]he PTO did not act arbitrarily or capriciously based on its treatment of reconsideration requests submitted by similarly situated patentees.

So the USPTO can act arbitrarily or capriciously as long as it does so towards a broad swath of patents?

The Federal Circuit rejected Daiichi Sankyo’s other arguments as having been rejected in Novartis AG v. Lee, which I wrote about here. Thus, the court affirmed the district court’s decision.

Deferential Review Of USPTO Decisions

Reading this opinion, I was struck at how little analysis was provided in support of the decision that the Interim Procedures were not arbitrary and capricious. This sentence seems particularly circular:

The PTO’s conclusion that its authority to conduct administrative reviews extends no further than the period for judicial review is also consistent with the statute, which expressly authorizes the PTO to make regulations governing the procedures of patent term adjustment reconsiderations. 35 U.S.C. § 154(b)(3)(A).

Doesn’t this say that the USPTO’s determination that the statute limits its authority to conduct administrative review later than 180 days after grant is supported by the statute’s delegation of authority to the USPTO to decide how to conduct administrative review?

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https://www.pharmapatentsblog.com/2015/07/07/post-wyeth-patent-term-adjustment-procedures/feed/0Examination Delay Earns Patent Term Adjustment Only In One Applicationhttps://www.pharmapatentsblog.com/2015/06/30/no-patent-term-adjustment-for-divisional-application/
https://www.pharmapatentsblog.com/2015/06/30/no-patent-term-adjustment-for-divisional-application/#respondTue, 30 Jun 2015 05:00:21 +0000http://www.pharmapatentsblog.com/?p=6148
In Mohsenzadeh v. Lee, the Federal Circuit affirmed the district court’s decision that the USPTO’s delay in issuing a Restriction Requirement in a parent application does not earn Patent Term Adjustment (PTA) for the ensuing divisional applications. Thus, while Mr. Mohsenzadeh’s parent application earned 1,476 days of “A Delay” for a late Restriction Requirement, his divisional...… Continue reading this entry]]>

In Mohsenzadeh v. Lee, the Federal Circuit affirmed the district court’s decision that the USPTO’s delay in issuing a Restriction Requirement in a parent application does not earn Patent Term Adjustment (PTA) for the ensuing divisional applications. Thus, while Mr. Mohsenzadeh’s parent application earned 1,476 days of “A Delay” for a late Restriction Requirement, his divisional applications did not.

I first wrote about this case shortly after the complaint was filed, and then when the district court decision was issued. As I explained in those articles, the patent application that issued as the parent ‘984 patent (the “parent application”) was filed July 6, 2001 and issued June 22, 2010. The USPTO awarded 2,104 days PTA to the ‘984 patent, including 1476 days of “A Delay” for the USPTO’s failure to issue a first Office Action within 14 months of the application’s filing date.

The first Office Action issued in the parent application was a Restriction Requirement mailed September 21, 2006, 1476 days after 14 months after the application was filed. The patent applications that issued as the ‘362 and ‘963 patents were filed on January 8, 2010. The ‘362 patent was issued on January 8, 2013, and the ‘963 patent was issued on March 19, 2013. The USPTO did not award any PTA to those patents.

Mr. Mohsenzadeh argued that the PTA calculations for the ‘362 and ‘963 patents should include the 1476 days of USPTO delay in issuing the Restriction Requirement in the parent application, because it is that Restriction Requirement that necessitated the filing of the applications that issued as the ‘362 and ‘963 patents.

The District Court Decision

The district court granted summary judgment in favor of the USPTO (and against Mr. Mohsenzadeh) for two reasons. First, the court determined that the language of the PTA statute (35 USC 154(b)) “plainly and unambiguously” only provides for PTA for delays that occurred during prosecution of the application from which the patent issued. Alternatively, the court found that to the extent the language of the PTA statute is ambiguous, the USPTO’s longstanding interpretation of the statute as set forth in 37 C.F.R. §§ 1.702,1.703, and 1.704(c)(12), is “reasonable and entitled to some deference.”

The Federal Circuit Decision

The Federal Circuit Decision was authored by Judge Reyna and joined by Judges Moore and Schall.

The Federal Circuit focused on the plain language of the PTA statute, and quickly disposed of Mr. Mohsenzadeh’s arguments:

The language of the provision of the patent term adjustment statute at issue, 35 U.S.C. § 154(b)(1)(A), clearly shows that Congress intended delay in the prosecution of an application to be restored to a single patent, the patent issuing directly from that application. In other words, the term of any patent arising from a continuing application is not restored for delay in the prosecution of the parent patent’s application.

The Impact Of Patent Term Adjustment

The district court decision includes this chart comparing the enforceable patent terms of the patents at issue:

As reflected in this chart, even though all of the patents had the same 20-year term, the ‘984 patent had a much longer enforceable term because of the PTA award and also because the divisional patents were filed several years later. Indeed, although the district court made note of it, the Federal Circuit did not comment on Mr. Mohsenzadeh’s decision to wait to several years after the Restriction Requirement to file the divisional applications.

Although this decision is not surprising, it does underscore the potential importance of which “invention” is elected for prosecution pursuant to a Restriction Requirement, especially one that is issued”late.” Often the first application in a family undergoes a longer prosecution than its divisional and continuation applications, creating the potential to earn significant PTA.